Clinical Pharmacology Scientist

vor 1 Woche

Basel, Schweiz Proclinical Vollzeit

Proclinical are recruiting Clinical Pharmacology Scientist for an international business. This is a contract role and is located in Basel, with the availability to work remotely from home. Our client is focused on detecting innovative remedies.

**Responsibilities**:

- Accountable for the scientific aspects of clinical pharmacology study protocol development, including protocol synopsis, consent form, eCRF and protocol amendments.
- Head the analysis of clinical pharmacology data (pharmacokinetics, pharmacodynamics, safety), co-operating as needed with operational staff and investigators, Data Management, Biostatistics and any other partners.
- Manage the continuing assessment of study data (e.g. PK, PD and safety) and analyse data outputs for scientific and medical validity and consistency.
- Support the arrangement of the clinical pharmacology component of the project specific Investigators Brochure.
- Direct the safety review of clinical pharmacology studies and participate to serious adverse event (SAE) reconciliation and SAE narratives.
- Attend and offer science support for investigator meetings and supervise workshops.
- Key scientific accountable for authoring final study reports.
- Contribute in the formulation of the IND and NDA documentation, the dossiers for official regulatory meetings (e.g. EOP1, EOP2) and resources for use in presentations and replies to regulatory authorities.
**Skills & Requirements**:

- Obtained MSc, Pharm D or PhD in pharmaceutical sciences, clinical pharmacology sciences (Post Doc considered).
- At least +2 years of experience in industry setting (preferably Pharma) supporting clinical pharmacology studies, NCA data analysis, associated DMPK analysis, regulatory filings and medical writing.
- Former experience / working knowledge of numerous methods to PK and PD data analysis: compartmental, curve-fitting, non-compartmental.
- Prior software experience: Phoenix? WinNonlin? (as well as Microsoft & Google Suites).
- Experience in clinical research, if possible, in the pharmaceutical business, with familiarity with ICH GCP and the drug development process.
- Understanding of operating on, and preferably guiding a team matrixed around the scientific and/or clinical study-related responsibilities.
- Operative teamwork and interpersonal skills (globally, internal and externally) involving training and mentoring.
- Efficient verbal and written communication/presentation skills in English.
- Exhibit creativity, critical thinking, initiative and conscientiousness
- Aptitude to process information, inspect data, and reach conclusions based on sound reasoning and the rationale based on the risk
- benefit examination and cost-effectiveness.
- Familiar with Spotfire? is advantageous but not essential to the role.
- Operate in a matrix structure for project.
- Represent function on team(s), answer to rudimentary protocol questions and process issues.
- Follow company values: Commitment, Initiative, Open Two-way Communication, Global Teamwork Trust, Accountability, Interdependence, Consistency, Empowerment, Sense of Urgency, Pride, Drive to Change, Courageous Leadership, Innovation.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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